drjobs Senior Clinical Pharmacologist -CDI

Senior Clinical Pharmacologist -CDI

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1 Vacancy
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Job Location drjobs

Toulouse - France

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Who we are

Pierre Fabre is the 2nd largest dermocosmetics laboratory in the world the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.

Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie Pierre Fabre Dermatologie Eau Thermale Avne Klorane Ducray Ren Furterer ADerma Naturactive Pierre Fabre Oral Care.


Established in the Occitanie region since its creation and manufacturing over 95% of its products in France the Group employs some 10000 people worldwide. Its products are distributed in about 130 countries.86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation a governmentrecognized publicinterest foundation while a smaller share is owned by its employees via an employee stock ownership plan.


In 2019 Ecocert Environment assessed the Groups corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the Excellence level.


Pierre Fabre is recognized as one of the Worlds Best Employers 2021 by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.

Your mission

Pierre Fabre R&D Medical Care is hiring a Senior Clinical Pharmacologist to join the PK/PD Group in Toulouse (site Langlade Oncopole France).

Your Key Responsibilities:

Project Leadership & Strategy

  • Lead the clinical pharmacology strategy as the PK representative in multidisciplinary project teams.
  • Define study needs timelines and budgets for key development phases (e.g. FIH Ph2/3 NDA submissions).
  • Contribute to the evaluation of external assets offering expert opinions to support business decisions.

Scientific & Operational Expertise

  • Oversee the design and execution of clinical and pharmacometric studies.
  • Collaborate closely with clinicians statisticians pharmacologists toxicologists CMC experts and regulatory specialists.
  • Partner with CROs KOLs and business partners to ensure successful study outcomes.

Documentation & Regulatory Interactions

  • Author scientific and regulatory documents including study protocols investigator brochures (IB) IND/IMPD NDA submissions and risk management plans (RMPs).
  • Represent the company in meetings with regulatory authorities technical experts and external stakeholders.

We offer an attractive remuneration/benefits package: Incentives profitsharing Pierre Fabre shareholding with matching contribution health and provident insurance 16 days of holidays (RTT) in addition to 25 days of personal holidays public transport participation very attractive CE...

Who you are

Education and Experience:

PhD MD or PharmD in pharmacokinetics pharmacometrics or a related scientific discipline with a minimum of 4 years of industry experience in clinical pharmacology and drug development
Proven track record of supporting drug development from early clinical phases (Ph1 /2/3) through regulatory submissions preferably in oncology dermatology or rare disease.


Expertise:
Indepth knowledge of PK/PD study design analysis and interpretation (NCA PBPK PopPK modeling).
Proficiency in pharmacometric software (e.g. WinNonlin NONMEM GastroPlus SimCYP R).
Strong understanding of EU and US regulatory requirements related to clinical pharmacology.


Skills & Competencies:
Strong analytical thinking and problemsolving skills.
Ability to collaborate effectively within crossfunctional teams and build productive external relationships.
Excellent communication skills both written and spoken in English (French is a plus).

We are convinced that diversity is a source of fulfillment social balance and complementarity for our employees which is why our offers are open to all without restriction.


Required Experience:

Senior IC

Employment Type

Full-Time

Company Industry

About Company

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